Advance Formula Pain Reliever Tablets Recall: Salicylic Acid Stability Issue
Ultra Seal Corporation recalls Advance Formula Pain Reliever tablets due to unstable salicylic acid levels. Affected lots have specific expiration dates and packaging details. Consumers should check their product labels for the lot numbers and expiration dates listed.
Lower-risk recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Contact the company
What happened, in plain English
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets because they contain unstable salicylic acid levels. This could lead to inconsistent medication effectiveness or potential safety issues if the product degrades over time. Read more at govinfonow.com/recall/35649-advance-formula-pain-reliever-tablets-recall-salicylic-acid-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/35649-advance-formula-pain-reliever-tablets-recall-salicylic-acid-stability-issue · Updated October 4, 2026 · FDA enforcement record: FDA #D-0075-2022
Cite this page
“Advance Formula Pain Reliever Tablets Recall: Salicylic Acid Stability Issue.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/35649-advance-formula-pain-reliever-tablets-recall-salicylic-acid-stability-issue. Based on FDA recall #D-0075-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0075-2022%22&limit=1).
Why it’s dangerous
The tablets contain a compound called salicylic acid that may degrade over time, leading to inconsistent medication levels. This could affect how well the pain reliever works or potentially cause unexpected reactions if the product degrades significantly.
Who’s affected
People who own or use the Advance Formula Pain Reliever tablets with the specific lot numbers and expiration dates listed in the recall notice are affected. Those who have the product in their possession or have taken it recently are at risk.
How to tell if you have this one
Check the product label for the lot numbers: AK-9457 (exp. 22-Jan), AK-9521 (exp. 22-Mar), AK-9959 (exp. 22-Dec), or AK-1017 (exp. 23-Jan). The product is packaged in 12,000 packets per case with specific expiration dates.
- Brand
Ultra Seal Corporation- Category
Drug
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0070-2022 | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label); Lot #: AK-9336, exp. date 21-Oct; K9406, AK-9407, exp. date 21-Dec; K-9860, exp. date 22-Oct; AK-1057, exp. date 23-Feb | 2,484,274 tablets |
| D-0071-2022 | Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label); Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep | 1,367,525 tablets |
| D-0072-2022 | ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label); Lot #: AK-9547, exp. date 22- Apr; AK-9941, exp. date 22-Dec | 1,968,150 tablets |
| D-0073-2022 | AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label ); Lot #: K-1278, exp. date 23-Jul; K-9371, AK-9463, exp. date 21-Nov; AK-9821, AK-9819, exp. date 22-Sep; 1107, exp. date 23-Mar. | 1,480,981 tablets |
| D-0074-2022 | North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK-9371, exp. date 21-Nov | 250,000 tablets |
| D-0075-2022 | Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label); Lot #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan | 991,310 tablets |
| D-0076-2022 | Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label); Lot #: K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun | 42,394,018 tablets |
| D-0077-2022 | Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label); Lot #: 9819, K-9819, exp. date 22-Sep | 519,600 tablets |
What to do — step by step
Check Product Label
Look for the lot numbers AK-9457, AK-9521, AK-9959, or AK-1017 on the packaging to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the product label for the lot numbers listed in the recall notice. If your product matches, you should stop using it and contact Ultra Seal Corporation for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0075-2022 (October 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0075-2022 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.